Pre-assembled Medical Fluid Flow System with Sterility Isolation
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Solution Overview
Problem
Disposable medical fluid flow systems pose manufacturing difficulties due to the need for different sterilization techniques for various components, leading to increased costs, administrative burdens, and risks of contamination and errors in assembly and usage.
Innovation Solution
A pre-assembled disposable medical fluid flow system with components sterilized using different techniques, featuring a fixed flow path with an isolated non-sterile portion and a micro-organism filter to maintain sterility, eliminating the need for separate spiking or electron beam radiation procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If pre-filled containers and fluid flow system are assembled separately and joined at user facility, then different sterilization techniques can be used for different components, but assembly complexity and risk of contamination increase
Solution Approach 1:
The patent combines the pre-filled container and fluid flow system into a single pre-assembled unit that is sterilized as one integrated system. This merging eliminates the need for separate sterilization of components and subsequent assembly at the user facility, thereby reducing assembly complexity and contamination risk while maintaining the ability to use appropriate sterilization techniques for the complete system.
Solution Approach 2:
The patent performs the assembly of the container and fluid flow system before sterilization, rather than after. This preliminary assembly allows the entire system to be sterilized together in a controlled manufacturing environment, preventing the need for complex post-sterilization assembly operations at the user facility and eliminating associated contamination risks.
2Reliability
If electron beam radiation is used to sterilize pre-assembled system, then sterility is achieved, but degradation of medical agent occurs
Solution Approach 1:
The patent applies different sterilization techniques to different portions of the system based on their specific requirements. The fluid flow system components are sterilized using methods appropriate for their material composition, while the pre-filled container with the medical agent is sterilized using a technique that does not degrade the agent, such as filtration or low-temperature plasma sterilization. This localized approach to sterilization maintains both sterility and agent integrity.
3Adaptability or versatility
If separate ordering and assembly of components is required, then flexibility is maintained, but administrative burden and error risk increase
Solution Approach 1:
The patent combines multiple components (pre-filled container, fluid flow system, and associated elements) into a single pre-assembled unit that is provided to the user as one integrated product. This eliminates the need for separate ordering, tracking, and assembly of individual components, thereby reducing administrative burden and assembly time while maintaining the flexibility to select different pre-filled container options during the ordering process.
4Ease of operation
If pre-sterilized components are exposed to non-sterile ambient environment during assembly, then assembly is simplified, but contamination risk increases
Solution Approach 1:
The patent performs the assembly of sterile components in a controlled sterile environment during manufacturing, before the components are exposed to the non-sterile ambient environment. The complete assembled system is then sterilized together, ensuring that no sterile surfaces are exposed to contamination risk during assembly operations. This eliminates the contradiction by performing assembly before rather than after sterilization.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system reduces manufacturing complexity and costs, minimizes the risk of contamination, and simplifies user assembly by ensuring sterility through the micro-organism filter, while avoiding the need for additional equipment and procedures.
Implementation Method 1
a micro-organism filter isolates the second sterilized fluid flow system component from the isolated portion of the flow path
Data Source
AI summary
A pre-assembled medical fluid flow system and method of making same are disclosed. The system includes a first sterilized fluid flow system component, a second sterilized fluid flow system component and a flow path for providing fluid communication therebetween. The flow path includes an isolated portion. An openable closure isolates the isolated portion from the first sterilized fluid system component, and a microorganism filter is disposed between and isolates the isolated portion of the flow path and the second sterilized fluid flow system component. Therefore, fluid from the isolated portion of the flow path must flow through the microorganism filter to reach the second sterilized fluid flow system component.